Medical conditions such as bladder disorders, bowel disorders, and sexual disorders affect the quality of life of millions of people in the United States and across the world. Turning to bladder disorders specifically, overactive bladder is a condition in which involuntary bladder contractions occur during bladder filling despite a person's attempt to suppress them. It causes symptoms such as urinary frequency and nocturia. Urge incontinence, which is the unintentional loss of urine caused by the bladder muscle contracting, and is usually associated with a sense of urgency, may also occur, as can stress incontinence. Stress incontinence happens when physical movement or activity (coughing, sneezing, running, etc.) puts pressure on the bladder and is distinguished from urge incontinence. The prevalence of urinary disorders such as overactive bladder, urge incontinence, and stress incontinence and their impact on quality of life is substantial, necessitating better treatment options. In addition, bowel disorders such as bowel incontinence or irritable bowel syndrome also affect the quality of life of many people, as can sexual disorders such as erectile dysfunction in some men, detrusor over-activity resulting in coital incontinence in some women, or persistent sexual arousal syndrome. The aforementioned urinary, bowel, and sexual disorders, which are associated with the pelvic region, can manifest themselves individually or in combination with each other. For instance, patients suffering from urge and/or stress incontinence may also suffer from bowel incontinence, while patients suffering from overactive bladder may also suffer from persistent sexual arousal syndrome.
Various treatments, for example, are available to mitigate bladder disorders such as overactive bladder, urge continence, or stress incontinence. Milder treatment options include lifestyle changes, bladder training, and pelvic floor exercises (i.e. kegel exercises). Such treatment options can also be used to mitigate bowel disorders or sexual disorders. Although these methods may help the person suffering from such disorders, they are time consuming and are often unsuccessful. Other treatment options include medication, surgery, and neuromodulation. Medication may not be desirable for some patients because of contraindications or lack of compliance. Surgery is reserved for persons that are severely affected by the aforementioned disorders because of possible complications such as blood clots, bowel obstruction, infection, and pneumonia. Neuromodulation treatments to mitigate bladder disorders, bowel disorders, and sexual disorders are showing promise and have become more popular.
Neuromodulation technologies use electrical stimulation to modulate nerves that are positioned deep beneath the skin's surface. The systems deliver electrical stimulation to the sacral, tibial, or pudendal nerves to modulate micturition (i.e. spinal) reflexes that are responsible for controlling the pelvic region where bladder disorders, bowel disorders, and sexual disorders manifest. Stimulation is delivered to these nerves either directly (i.e. invasively) or indirectly, and acts on different parts of the reflex pathway, yielding different outcomes. The use of such technology can be effective in the treatment of persons with bladder disorders as well as persons with bowel disorders, or sexual disorders, including persons who have failed pharmacological therapies. Invasive procedures are expensive and can lead to surgical complications, while non-invasive procedures can be painful or cause discomfort.
As such, there remains a need for a safe, effective, and non-invasive method to monitor and treat the symptoms of bladder disorders, bowel disorders, or sexual disorders that can be administered by an individual with or without the assistance of a doctor, nurse, or other medical professional in an efficient manner and without causing the individual pain.